Back to resultsA Study of Atezolizumab in Unresectable or Advaced Malignant Pleural Mesothelioma
Primary Purpose
Malignant Pleural Mesothelioma, Advanced, Malignant Pleural Mesothelioma, Unresectable
Status
Withdrawn
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Atezolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Pleural Mesothelioma, Advanced focused on measuring Malignant Pleural Mesothelioma, Atezolizumab, Thoracic neoplasms, Antibodies, monoclonal, Antineoplasic, agents
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent form.
- Patients have ≥18 years of age.
- Diagnosis of malignant pleural mesothelioma histologically confirmed by certified pathologist.
- Unresectable and/or advanced disease, based on the Seventh Edition American Joint Committee on Cancer (AJCC) Cancer Staging Manual. Patients with MPM diagnosed with early disease and whose comorbidities make them ineligible for surgical procedures or who do not accept surgery treatment.
- Patients should have received at least one platinum-based treatment and should have reported progression after at least two treatment cycles.
- Disease measurable as per the Response Evaluation Criteria in Solid Tumors (RECIST) modified for mesothelioma.
- ECOG performance status ≤2.
- >12-week life expectancy.
- Patients with adequate organ function
- Patients should have recovered to grade ≤1 in all adverse events associated with previous antineoplastic therapies, excluding alopecia.
- Patients should be able to comply with protocol procedures, at the discretion of the investigator
- Patients of both genders who are potentially fertile should use effective contraceptive methods (barrier methods plus other contraceptive methods) before study entry and during their participation in the study.
Exclusion Criteria:
- Patients diagnosed with another tumor, except for treated cervical carcinoma in situ, epidermoid carcinoma, or superficial bladder cancer (Ta and Tis), or other malignancy for which healing therapy was administered within 5 years before study enrollment.
- Simultaneous participation in another study on a study drug, or if the patient participated in a study within 28 days before study treatment initiation.
- Medical history of interstitial lung disease (ILD), drug-induced interstitial disease, radiation pneumonitis that required treatment with steroids, or any sign of clinically active interstitial lung disease.
- Use of systemic immunosuppressive therapy (use of steroids with a dose >10 mg of prednisone or other immunosuppressive therapy).
- Presence of active autoimmune disease.
- Suspicion or certainty of symptomatic brain metastasis or spinal cord compression. Patients with asymptomatic and stable brain metastasis are eligible for the study.
- Pregnant or breastfeeding women. Women of childbearing potential must have a negative pregnancy test carried out within 7 days prior to treatment initiation.
- Patient previously treated with immunotherapy (PD-1/PD-L1 inhibitors).
- Major surgery within 4 weeks prior to study treatment initiation or expected major surgery during the course of the study for non-diagnostic purposes.
- Known seropositivity for human immunodeficiency virus (HIV). tory or symptoms of HIV may enter the study only if there is negative serology.
- Active tuberculosis.
- Administration of a live attenuated vaccine within 4 weeks prior to study treatment initiation or at any moment during the course of the study.
- Last chemotherapy cycle within 30 days prior to first treatment administration.
- Any unstable disease or condition that may threaten the patient's safety and/or the patient's study compliance.
- Drug addiction or clinical, psychological, or social disorders that may undermine the informed consent validity or affect compliance with protocol.
Sites / Locations
- Health Pharma Professional Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Atezolizumab
Arm Description
Participants with unresectable or advanced malignant pleural mesothelioma who have progressed after platinum-based chemotherapy will receive atezolizumab 1200 mg every 21 days, until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).
Outcomes
Primary Outcome Measures
Objective Response Rate
The number of subjects whose best confirmed objective response is a CR or PR, divided by the number of treated subjects
Secondary Outcome Measures
Progression-free survival
The time from the date of the start of treatment to the date of the first documented tumor progression as determined by RECIST v 1.1, or death, whichever occurs first
Duration of response
The time from documentation of tumor response to disease progression as determined by RECIST v1.1
Overall survival
The time from the date of the start of treatment until death from any cause
Safety of atezolizumab
The incidence of treatment-related adverse events assessed by CTCAE v4.03
Health Related Quality of Life (HRQoL) Scores
Change from Baseline in Health Related Quality of Life (HRQoL) Scores as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)
Patient Functioning and Symptoms Score
Change from Baseline in Patient Functioning and Symptoms Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module LC-13 (QLQ-LC13)
Full Information
NCT ID
NCT03786419
First Posted
December 18, 2018
Last Updated
May 11, 2021
Sponsor
Health Pharma Professional Research
1. Study Identification
Unique Protocol Identification Number
NCT03786419
Brief Title
A Study of Atezolizumab in Unresectable or Advaced Malignant Pleural Mesothelioma
Official Title
Phase II Study to Evaluate the Efficacy and Safety of Atezolizumab in Subjects With Unresectable or Advanced Malignant Pleural Mesothelioma Who Experienced Progression on Platinum-Based Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Publication of study results of ICI use in MPM as first line therapy
Study Start Date
August 2020 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Health Pharma Professional Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a national, single arm, phase II trial in patients with diagnosis of unresectable or advanced malignant pleural mesothelioma who experienced progression after platinum-based chemotherapy.
Detailed Description
The study includes a screening period a treatment period, a termination treatment visit ≤30 days following the last dose of the study drug, and a follow-up period. Day 1 is defined as the first day in which patients receive atezolizumab. The study is expected to enroll 36 patients.
Enrolled patients will receive a fixed dose of atezolizumab 1200 mg administered intravenously the first day of each cycle. A treatment cycle will last 21 days (± 3 days). Treatment with atezolizumab will continue until investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).
Treatment with atezolizumab may continue while patients experience clinical benefit based on the investigator's assessment (absence of unacceptable toxicity or symptomatic deterioration attributable to disease progression, at the discretion of the investigator after evaluating radiographic data, biopsy results [if available], and clinical status), or until unacceptable toxicity or death.
During treatment, patients treated with atezolizumab, who demonstrate evidence of clinical benefit may continue treatment with atezolizumab after meeting disease progression criteria, based on the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The following need to be met, as specified by the protocol.
All patients must undergo tumor assessments at baseline and every 9 weeks (± 7 days) following cycle 1, day 1, regardless of treatment delays, until radiographic disease progression, as per RECIST v1.1 modified for mesothelioma, or loss of clinical benefit in patients treated with atezolizumab, who continue treatment beyond disease progression, as per RECIST v1.1, withdrawal of consent, death or study termination by principal investigator, whichever occurs first.
The study will end if all enrolled patients die, withdraw their consent, become lost to follow-up, or have been monitored during 12 months from the enrollment of the last patient, whichever occurs first.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Mesothelioma, Advanced, Malignant Pleural Mesothelioma, Unresectable
Keywords
Malignant Pleural Mesothelioma, Atezolizumab, Thoracic neoplasms, Antibodies, monoclonal, Antineoplasic, agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atezolizumab
Arm Type
Experimental
Arm Description
Participants with unresectable or advanced malignant pleural mesothelioma who have progressed after platinum-based chemotherapy will receive atezolizumab 1200 mg every 21 days, until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq, RO5541267, MPDL3280A
Intervention Description
Participants will be given 1200 mg of Atezolizumab as single agent by IV infusion every 21 days. First infusion will be over 60 min. Subsequent Atezolizumab cycles may be administered for 30 minutes, if there were no perfusion-related toxicity
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
The number of subjects whose best confirmed objective response is a CR or PR, divided by the number of treated subjects
Time Frame
From the time of initial response until documented tumor progression or death, whichever occurs first (up to approximately 4 years)
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
The time from the date of the start of treatment to the date of the first documented tumor progression as determined by RECIST v 1.1, or death, whichever occurs first
Time Frame
Baseline up to disease progression or death, whichever occurs first (up to approximately 4 years)
Title
Duration of response
Description
The time from documentation of tumor response to disease progression as determined by RECIST v1.1
Time Frame
Baseline up to disease progression or death, whichever occurs first (up to approximately 4 years)
Title
Overall survival
Description
The time from the date of the start of treatment until death from any cause
Time Frame
Baseline up to 1 year after treatment discontinuation
Title
Safety of atezolizumab
Description
The incidence of treatment-related adverse events assessed by CTCAE v4.03
Time Frame
Baseline up to 60 days after the last dose of the study drug or until another oncologic treatment is initiated, whichever occurs first
Title
Health Related Quality of Life (HRQoL) Scores
Description
Change from Baseline in Health Related Quality of Life (HRQoL) Scores as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)
Time Frame
Baseline until 1 year after treatment discontinuation or death, whichever occurs first
Title
Patient Functioning and Symptoms Score
Description
Change from Baseline in Patient Functioning and Symptoms Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module LC-13 (QLQ-LC13)
Time Frame
Baseline until 1 year after treatment discontinuation or death, whichever occurs first
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent form.
Patients have ≥18 years of age.
Diagnosis of malignant pleural mesothelioma histologically confirmed by certified pathologist.
Unresectable and/or advanced disease, based on the Seventh Edition American Joint Committee on Cancer (AJCC) Cancer Staging Manual. Patients with MPM diagnosed with early disease and whose comorbidities make them ineligible for surgical procedures or who do not accept surgery treatment.
Patients should have received at least one platinum-based treatment and should have reported progression after at least two treatment cycles.
Disease measurable as per the Response Evaluation Criteria in Solid Tumors (RECIST) modified for mesothelioma.
ECOG performance status ≤2.
>12-week life expectancy.
Patients with adequate organ function
Patients should have recovered to grade ≤1 in all adverse events associated with previous antineoplastic therapies, excluding alopecia.
Patients should be able to comply with protocol procedures, at the discretion of the investigator
Patients of both genders who are potentially fertile should use effective contraceptive methods (barrier methods plus other contraceptive methods) before study entry and during their participation in the study.
Exclusion Criteria:
Patients diagnosed with another tumor, except for treated cervical carcinoma in situ, epidermoid carcinoma, or superficial bladder cancer (Ta and Tis), or other malignancy for which healing therapy was administered within 5 years before study enrollment.
Simultaneous participation in another study on a study drug, or if the patient participated in a study within 28 days before study treatment initiation.
Medical history of interstitial lung disease (ILD), drug-induced interstitial disease, radiation pneumonitis that required treatment with steroids, or any sign of clinically active interstitial lung disease.
Use of systemic immunosuppressive therapy (use of steroids with a dose >10 mg of prednisone or other immunosuppressive therapy).
Presence of active autoimmune disease.
Suspicion or certainty of symptomatic brain metastasis or spinal cord compression. Patients with asymptomatic and stable brain metastasis are eligible for the study.
Pregnant or breastfeeding women. Women of childbearing potential must have a negative pregnancy test carried out within 7 days prior to treatment initiation.
Patient previously treated with immunotherapy (PD-1/PD-L1 inhibitors).
Major surgery within 4 weeks prior to study treatment initiation or expected major surgery during the course of the study for non-diagnostic purposes.
Known seropositivity for human immunodeficiency virus (HIV). tory or symptoms of HIV may enter the study only if there is negative serology.
Active tuberculosis.
Administration of a live attenuated vaccine within 4 weeks prior to study treatment initiation or at any moment during the course of the study.
Last chemotherapy cycle within 30 days prior to first treatment administration.
Any unstable disease or condition that may threaten the patient's safety and/or the patient's study compliance.
Drug addiction or clinical, psychological, or social disorders that may undermine the informed consent validity or affect compliance with protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Arturo Alatorre Alexander, MD
Organizational Affiliation
Health Pharma Professional Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Pharma Professional Research
City
Mexico City
ZIP/Postal Code
03810
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Atezolizumab in Unresectable or Advaced Malignant Pleural Mesothelioma
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